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Electrocardiogram Clinical Validation Study

NCT04842123 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2022-02-03

No results posted yet for this study

Summary

The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.

Conditions

Interventions

DIAGNOSTIC_TEST

Electrocardiogram

Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.

Sponsors & Collaborators

  • Garmin International

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-10-04
Completion
2021-10-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842123 on ClinicalTrials.gov